Neuorological condition detection unit and method of using the same

ABSTRACT

A neurological condition detection unit can include a computer device that is connected to at least two leads that are connectable to a patient for evoking a response from that patient via an electrical current passed through the leads (e.g. a shock) and at plurality of sensors connected to the computer device to sense how the left side and right side of the patient&#39;s brain reacts to the evoked event (e.g. the shock). The stroke detection device and/or neurological condition detection unit can be configured to output a warning when one side of the patient&#39;s brain is determined to react differently than the opposite side of the patient&#39;s brain by at least a pre-selected threshold value. The warning can include an identification of a nearby care facility that may be best suited for providing care to a patient determined to have a neurological condition (e.g. a stroke).

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims priority to U.S. Provisional PatentApplication No. 62/143,364, which was filed on Apr. 6, 2015.

FIELD OF INVENTION

The present invention relates to devices configured to detect a strokeand/or a condition indicative of at least one neurological disease andmethods of using such devices.

BACKGROUND OF THE INVENTION

It can often be difficult for emergency responders or minimally trainedmedical personnel to detect a patient having a stroke or detect apatient who is about to have a stroke. For instance, medics, such asparamedics, emergency service (“EMS”) personnel, or emergency medicaltechnician (“EMT”) personnel are often unable to readily detect whethera patient has experienced a stroke. Often, medics will take a patient tothe nearest hospital, which may not be able to provide care to strokepatients. For instance, only about 1 in 7 hospitals are currentlyconfigured as stroke centers.

Currently, a computerized tomography (CT) scan is often the onlyobjective method regularly used to detect whether a patient hasexperienced a stroke. But, a CT scanner can be difficult to incorporateinto tools an emergency responder or other patient care provider mayregularly use, such as an ambulatory vehicle, urgent care center, orgeneral practitioner doctor's office. Therefore, pre-hospital providersoften only have subjective clinical exams to rely upon for the detectionof a stroke in a patient, which are in large part dependent on the skilland experience of a particular care provider.

SUMMARY OF THE INVENTION

A neurological condition detection unit, a stroke detection device,methods of using such devices, and methods of detecting a stroke forrouting of an ambulance (e.g. ambulatory truck, van, boat, airplane,helicopter or other vehicle transporting a patient to a hospital) areprovided herein. Embodiments of the stroke detection device and/orneurological condition detection unit can include a computer device thatis connected to at least two leads that are connectable to a patient forevoking a response from that patient via an electrical current passedthrough the leads (e.g. a shock) and a plurality of sensors connected tothe computer device to sense how the left side and right side of thepatient's brain reacts to the evoked event (e.g. the shock). The strokedetection device and/or neurological condition detection unit can beconfigured to output a warning when a comparison of two or more areas ofthe patient's brain reacts to the evoked event (e.g. the shock) showsthat one area has responded substantially differently than another areato the evoked event (e.g. the shock). For instance, a stroke may bedetected when one side of the patient's brain is determined to reactdifferently than the opposite side of the patient's brain by at least apre-selected threshold value. The warning that is output may becommunicated by the stroke detection device so that a warning isdisplayed via an output device (e.g. a display and/or a speaker, etc.)to inform an emergency responder, such as a medic, that the patient hasexperienced a stroke or may have experienced a stroke so that thepatient can be transported to a hospital that is capable of providingeffective treatment for the patient. Embodiments of the neurologicalcondition detection unit can be configured to provide physiological datato for an out-of-hospital patient so that a pre-hospital care provider(e.g. medic, emergency responder, other minimally trained medicalassistant, etc.) can utilize the unit to obtain objective physiologicaldata that may facilitate detection of a stroke or other neurologicalcondition without requiring substantial reliance on the care giver'sskill and experience.

In some embodiments, the neurological condition detection unit can beconfigured so that electrodes and sensors need not be placed in the hairof a patient (e.g. after shaving or otherwise removing hair on the headof a patient or after removal of hair on the arms or legs of a patient,etc.). Such embodiments can allow for easy electrode and sensorplacement that allows for relatively quick placement for detecting aneurological condition via the unit.

In some embodiments, a method for detecting a neurological conditionincludes the steps of attaching evoked electrodes on opposite sides of abody, positioning sensors on the opposite sides of the body,communicatively connecting the evoked electrodes and the sensors to acomputer device having non-transitory memory connected to a processor,using the computer device to shock the body via the evoked electrodesfor a pre-selected number of shocks within a pre-selected time period,the computer device generating at least one of wave forms and curvesthat identify morphological features for responses from the pre-selectednumber of shocks the opposite sides of the body are measured to have,the computer device comparing the morphological features to determine adifference between a morphological feature for a left side of the bodyand a morphological feature for a right side of the body that is at orexceeds a pre-selected threshold, and the computer device generating anotification to identify a detection of a neurological condition inresponse to a result of the comparing of the morphological featuresindicating that the difference between the morphological feature for theleft side of the body and the morphological feature for the right sideof the body is at or exceeds the pre-selected threshold.

In some embodiments the at least one of the wave forms and the curvesare generated from measurement data the computer device receives fromthe sensors. This data may also be generated after filtration ofmeasurement data and processing such data to remove noise or othercomponents of the measurement data that may be considered inaccuratedata or data having no little significance to the evaluation of thepatient's condition. For instance, some embodiments of the method canalso include filtering measurement data received from the sensors forgenerating the at least one of the wave forms and the curves. The methodcan also include other steps. For instance, the method can include thecomputer device receiving the measurement data from the sensors andstoring the measurement data in the memory. The storage of the data mayoccur before the data is filtered and/or otherwise processed.

In some embodiments, the morphological features can be amplitudes andthe responses from the pre-selected number of shocks the opposite sidesof the body can be electrical responses a central nervous system of thebody has to the pre-selected number of shocks.

The notification can includes indicia identifying a location of ahospital determined to be most capable of providing care for theneurological condition. The computer device can also search at least onedata store to identify a hospital based on the detected neurologicalcondition that may be best qualified to treat that condition within apre-selected distance of the computer device and/or patient andcommunicate data to an output device for identifying directions forrouting an ambulatory vehicle to the hospital during implementation ofthe method. Additionally, the computer device can communicate data to acommunication system of the hospital relating to the detection of theneurological condition.

In some embodiments, the evoked electrodes can be on pads that areadhesively attached to the body for removable attachment to the body andthe sensors can be on at least one pad that is adhesively attached tothe body. In some embodiments, the pads having the evoked electrodes canalso have at least one of the sensors. These pads may have coveringsthat cover the adhesive portions of the pads. Each of the coverings canhave indicia identifying a location on which the pad of that covering isto be positioned on the body. Embodiments of the method can also includethe step of removing the coverings that cover adhesive portions of thepads prior to those pads being positioned on a patient. The evokedelectrodes can be positioned adjacent left and right wrists of the bodyand the sensors can be positioned on a head of the body or on a neck ofthe body in some embodiments of the method. The indicia of the coveringsmay identify these locations for these embodiments.

In other embodiments, the evoked electrodes are on gloves or in glovesand the attaching of the evoked electrodes on opposite sides of the bodyincludes inserting hands of the body into the gloves. The gloves can beconfigured to have one or more visual verification mechanisms that canbe viewed by a medic or other care provided to verify that the glovesare not twisted or otherwise improperly positioned on the patient.

In some embodiments of a neurological condition detection unit, the unitcan include non-transitory memory, a processor connected to the memory,a plurality of evoked electrodes connectable to the neurologicalcondition detection unit such that a pre-selected number of shockswithin a pre-selected time period is transmittable into a body of apatient via the evoked electrodes, and a plurality of sensorscommunicatively connectable to the memory such that measurement datarelating to responses opposite sides of the body of the patient have tothe shocks is storable in the memory. The neurological conditiondetection unit can be configured to utilize the measurement data togenerate at least one of wave forms and curves that identify amplitudesfor responses from the shocks the opposite sides of the body aremeasured to have, compare the amplitudes to determine a differencebetween an amplitude for a left side of the body and an amplitude for aright side of the body that is at or exceeds a pre-selected threshold;and generate a notification to identify a detection of a neurologicalcondition in response to a result of the comparing of the amplitudesindicating that the difference between the amplitude for the left sideof the body and the amplitude for the right side of the body is at orexceeds the pre-selected threshold.

In some embodiments, the neurological condition detection unit ispositioned in an ambulatory vehicle so that the device is portable ormobile. The neurological condition detection unit can also include atleast one wireless transceiver unit configured to communicativelyconnect the processor and the memory to the sensors and/or the evokedelectrodes.

Embodiments of the neurological condition detection unit can alsoinclude a power source connected to the evoked electrodes such thatelectricity is transmittable into the body via the evoked electrodes.The power source may be a battery within a housing of a computer deviceor may be a battery of a vehicle in which the neurological conditiondetection unit is positionable or may be an engine of a vehicle in whichthe neurological condition detection unit is positionable. In someembodiments, the neurological condition detection unit may be portableand be positionable outside of a vehicle but still be coupled to thevehicle engine and/or battery as its power source for providing power toevoked electrodes.

In some embodiments, the sensors are on at least one pad that isconfigured to adhesively attach to the body and the evoked electrodesare on pads that are configured to adhesively attach to the oppositesides of the body. The pads can each have a covering that removablycovers adhesive of the pad that is configured to adhesively attach thepad to the body. The covering can have indicia identifying a location onthe body to which the pad is to be attached.

It is contemplated that some embodiments of neurological conditiondetection unit can include non-transitory memory, a processor connectedto the memory, one or more visual stimulation mechanisms connectable tothe neurological condition detection unit such that a pre-selectednumber of visual stimulation within a pre-selected time period istransmittable into one or more eyes of a patient via the visualstimulation mechanisms, and a plurality of sensors communicativelyconnectable to the memory such that measurement data relating toresponses opposite sides of the body of the patient have to the visualstimuli is storable in the memory. The neurological condition detectionunit can be configured to utilize the measurement data to generate atleast one of wave forms and curves that identify amplitudes forresponses from the visual stimuli the opposite sides of the body aremeasured to have, compare the amplitudes to determine a differencebetween an amplitude for a left side of the body and an amplitude for aright side of the body that is at or exceeds a pre-selected threshold,and generate a notification to identify a detection of a neurologicalcondition in response to a result of the comparing of the amplitudesindicating that the difference between the amplitude for the left sideof the body and the amplitude for the right side of the body is at orexceeds the pre-selected threshold.

It is also contemplated that embodiments of the method for detecting aneurological condition can include positioning at least one visualstimulation device to on a head of a patient, positioning sensors on theopposite sides of the body of the patient, communicatively connectingthe at least one visual stimulation device and the sensors to a computerdevice having non-transitory memory connected to a processor, using thecomputer device to actuate visual stimuli to the eyes of the patient viathe one or more visual stimulation devices for a pre-selected number ofvisual stimuli within a pre-selected time period, the computer devicegenerating at least one of wave forms and curves that identifymorphological features for responses from the pre-selected number ofvisual stimuli the opposite sides of the body are measured to have, thecomputer device comparing the morphological features to determine adifference between a morphological feature for a left side of the bodyand a morphological feature for a right side of the body that is at orexceeds a pre-selected threshold, and the computer device generating anotification to identify a detection of a neurological condition inresponse to a result of the comparing of the morphological featuresindicating that the difference between the morphological feature for theleft side of the body and the morphological feature for the right sideof the body is at or exceeds the pre-selected threshold.

In some embodiments of the method or neurological condition detectionunit, the computer device or the neurological condition detection unitcan also be configured to utilize multiple evoked electrodes forproviding evoked potential via electrical stimulation to a patient inaddition to use of the visual stimulation via one or more visualstimulation devices and/or visual stimulation mechanisms.

In some embodiments, the visual stimulation mechanisms and/or the visualstimulation devices may include one or more light emitting devices suchas light emitting diodes or one or more pen lights. These mechanisms mayhave a wireless communicative connection and/or a wired connection to acomputer device and/or a component of the neurological conditiondetection unit.

Other details, objects, and advantages of the invention will becomeapparent as the following description of certain exemplary embodimentsthereof and certain exemplary methods of practicing the same proceeds.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of a neurological condition detection unit areshown in the accompanying drawings and certain exemplary methods ofpracticing the same are also illustrated therein. It should beappreciated that like reference numbers used in the drawings mayidentify like components.

FIG. 1 is a block diagram of a first exemplary embodiment of aneurological condition detection unit.

FIG. 2 is a flow chart illustrating a first exemplary method of usingneurological condition detection unit.

FIG. 3 is a flow chart illustrating an exemplary method by which thefirst exemplary embodiment of the neurological condition detection unitcan be configured to collect and store data for use in assessing whethera patient has experienced a stroke.

FIG. 4 is flow chart illustrating an exemplary method by which the firstexemplary embodiment of the neurological condition detection unit can beconfigured to detect a stroke based on data collected from a patientresponding to at least one evoked event (e.g. at least one electricalshock at a pre-selected electrical current value).

FIG. 5 is a block diagram illustrating the first exemplary embodiment ofthe neurological condition detection unit in a communication system inwhich the neurological condition detection unit can be communicativelyconnected to other remote devices via a network connection (e.g. a widearea network connection or other type of network connection).

FIG. 6 is a perspective view of a sensor and electrode kit havingelectrodes and sensors for positioning on a patient that may be utilizedin the first exemplary embodiment of the neurological conditiondetection unit. An optional head wearable component of the kit havingvisual stimulation mechanisms is shown in broken line in FIG. 6.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Referring to FIGS. 1-5, embodiments of a neurological conditiondetection unit can be configured as a stroke detection device, or strokedetection apparatus. This device can include a computer device 1. Thecomputer device 1 can be an electronic device that is electricallyconnected to an electrical circuit of an ambulance 9. For instance, apower source 8 of an ambulance 9 (e.g. an ambulatory vehicle such as amedical helicopter, ambulatory truck, ambulatory van, etc.) can beelectrically connected to the computer device 1 to transmit electricityto the computer device 1 to power the computer device 1. In someembodiments, the power source 8 can be a battery of the ambulance or theinternal combustion motor of the ambulance 9. In other embodiments, thepower source may be a battery that is located in a housing of thecomputer device or is another type of electrical power source configuredto provide electricity to the computer device 1 to power the operationof the computer device 1.

The computer device can include hardware. The hardware may include aprocessor unit 1 a that is communicatively connected to non-transitorymemory 1 b and at least one first transceiver unit 1 c. Thenon-transitory memory may be internal memory of the computer device,flash memory, a hard drive, or other type of tangible, non-transitorycomputer readable medium. The memory 1 b can store at least oneapplication 1 d and at least one data store 1 e. The application may bea computer program having code that is executed by the processor 1 a sothat the computer device 1 performs a method defined by the code. Thecode may include code that requires use of predefined functions, datastored in data stores 1 e, or data to be received from other elementsconnected to the processor 1 a when the processor is running theapplication to perform the method defined by the code. The data store 1e can be one or more databases or other type of data stored in thememory 1 b. The processor unit 1 a can be an electrical processor suchas a central processing unit (“CPU”), at least one microprocessor, atleast one core processor, interconnected processors that are connectedin series or in parallel, or other type of processor electrical device.The first transceiver unit 1 c can include at least one receiver and atleast one transmitter. The first transceiver unit 1 c can include aninterface for permitting the processor unit 1 a and/or memory 1 b toreceive data from and/or provide data to other devices, such as an inputdevice 2, an output device 4, an input/output device 6, and/or aplurality of sensors (e.g. first sensor 3 a, second sensor 3 b, andthird sensor 3 c, etc.). The sensors may be configured to detectelectrical potentials or other type of neural signals from a patient. Insome embodiments, the sensors may be combined with infrared sensors todetect blood oxygen saturation or temperature as well.

The number of sensors that are used in embodiments of the device caninclude any number of different arrays of sensors. For instance, theremay be more than two sensors, more than three sensors more than fivesensors, or more than 10 sensors that are used. In some embodiments, thesensors may be included in one or more pads, one or more patches, aheadband, one or more wearable straps, one or more wearable bands or inother wearable mechanisms that may be configured to facilitateattachment of the sensors to a patient at desired locations.

The first transceiver unit 1 c can also be configured so that theprocessor 1 a is communicatively connectable to other devices such as atleast one hospital communication device 13 and/or a communication devicehosting a location service 11. The processor unit 1 a can also beconnected to at least one second transceiver unit if and an electricitytransmitter unit 1 g.

Each input device can be a device configured to allow a user to provideinput to a processor unit 1 a. For instance, demographic informationabout a patient may be input by a provider using an input device (e.g.keyboard, mouse, touch screen, etc.) to identify the sex of a patient,the age or age range of the patient (e.g. 27 years old or 25-35 yearsold, or an age within 5 or 10 years of the patients actual age, etc.).Other information about the patient can also be provided as input to thedevice via an input device. The entered information can be stored in thememory of the device for use by the device when assessing the patient'sresponses to evoked potential, or “shocks” that may be provided to thepatient via electrodes.

An input device can include a touch screen display, a stylus, akeyboard, a pointer device, a mouse, a keypad, one or more buttons, amicrophone, or other type of input mechanism. Some of the input devicesmay be internal to a housing of the computer device 1 and becommunicatively connected to the processor 1 a via wiring or othercommunicative connection. Input devices 2 may also (or alternatively) becommunicatively connected to the processor 1 a via a short range radioconnection (e.g. a Bluetooth connection or near field communicationconnection) or a wired connection (e.g. a Universal Serial Bus (“USB”)connection).

Each output device may be a device configured to output data to a user.Examples of an output device 4 that may be connected to the processor 1a of the computer device 1 include a display unit, a liquid crystaldisplay, a monitor, a printer, at least one speaker, or other type ofoutput mechanism. Some of the output devices may be internal to ahousing of the computer device 1 and be communicatively connected to theprocessor 1 a via wiring or other communicative connection. Outputdevices 4 may also (or alternatively) be communicatively connected tothe processor 1 a via a short range radio connection (e.g. a Bluetoothconnection) or a wired connection (e.g. a USB connection).

Input/output devices 6 that may be connected to the processor unit 1 acan be configured to provide output to a user and can also be configuredto provide input to the processor 1 a. Examples of an input/outputdevice can include a touch screen display device. Some of theinput/output devices may be internal to a housing of the computer device1 and be communicatively connected to the processor 1 a via wiring orother communicative connection. Input/output devices 6 may also (oralternatively) be communicatively connected to the processor 1 a via ashort range radio connection (e.g. a Bluetooth connection) or a wiredconnection (e.g. a USB connection).

Each input device 2, output device 4 and/or input/output device 6 can becommunicatively connected to the processor 1 a and/or memory 1 b via thefirst transceiver unit 1 c. Alternatively, a second transceiver unit ifcan be configured to communicatively connect these elements to theprocessor unit 1 a and/or memory 1 b. For instance, in some embodiments,the first transceiver unit 1 c can be configured to providecommunication connections via a first type of connection mechanism (e.g.a wireless network connection, a local radio connection, a wiredcommunicative connection, a wireless connection to a base station of awide area network or cellular network, etc.) and the second transceiverunit if can be configured to provide a second type of communicativeconnection (e.g. a USB connection). In yet other embodiments, thecomputer device 1 can include multiple other types of transceiver units.In yet other embodiments, the first transceiver unit 1 c can beconfigured to include multiple different types of transceivers forcommunicative connections of the computer device 1 to different devicesvia different types of connection protocols or methodologies.

The electricity transmitter 1 g can be connected to multiple leads suchas, for example, a first evoked electrode 5 a and a second evokedelectrode 5 b. Each evoked electrode can be attached to a pad forattachment to or positioning on a patient and can be configured for thetransmission of stimuli to an object. For instance, each evokedelectrode may be configured to include an anode and a cathode and theelectricity transmitter 1 g can be connected to these evoked electrodesso that an electrical current can be transmitted to these electrodes forbeing transmitted to another object, such as a patient. Each evokedelectrode can be included as a component of a wrist band, ankle band,behind the knee band, or other type of strap, patch or other type ofwearable device configured for being placed in contact on a humanpatient. For instance, the first evoked electrode 5 a may be connectedto a first strap configured to be placed around a patient's left wrist,left ankle, left shoulder, left thorax, or behind the patient's leftknee so that the first evoked electrode 5 a is in contact with thepatient's skin near a nerve on the left side of the patient's body thesecond evoked electrode 5 b may be connected to a second strap that isconfigured to be placed around a patients right wrist, right ankle,behind the patient's right knee, on the patient's right shoulder, orright thorax so that the second evoked electrode 5 b contacts thepatient's skin near a nerve on the right side of the patient's body. Theevoked electrodes may be positioned so that they are positioned on themedian nerves of the patient on the left and right sides of the patient.The evoked electrodes may also (or alternatively), be positioned on theulnar, tibial, peroneal (also known as the fibular), auxiliary,musculocutaneous, brachial plexus, accessory nerves and/or other sensorynerves that communicate with the central nervous system (e.g.somatosensory cortex and/or other parts of the central nervous system).

In some embodiments, the positioning of the first and second evokedelectrodes 5 a, 5 b can correspond to one another on opposite sides of apatient for being positioned on opposite sides of a patient's nerve oron corresponding sides of the same type of nerve of the patient. Forinstance, if the first evoked electrode 5 a is positioned on a patient'sleft wrist, the second evoked electrode 5 b may be placed on thepatient's right wrist so that the positions of the first and secondevoked electrodes correspond to one another on opposite sides of thepatient. As another example, if the first evoked electrode 5 a ispositioned on a patient's right ankle, the second evoked electrode 5 bmay be placed on the patient's left ankle so that the positions of thefirst and second evoked electrodes correspond to one another on oppositesides of the patient.

The electricity transmitter can be configured to transmit electricity toeach evoked electrode so that a current of 5 milliamps (mA), a currentof no greater than 200 mA, or another current having a pre-selectedvalue (e.g. 5 mA to 200 mA, 50 mA to 200 mA, 50 mA, 200 mA, or greaterthan 200 mA or less than 5 mA but greater than 0 mA, etc.) is passedinto the patient having the first and second evoked electrodes 5 a, 5 b(as well as any other additional evoked electrodes) contacting thepatient's body so that a sensory evoked potential can be generated inthe patient's body in response to the shock provided by the current. Thecurrent may be continuously transmitted by the electricity transmitterunit 1 g for a pre-selected time range, such as, for example less than 1second, less than 0.5 seconds, less than 0.33 seconds, less than 0.25seconds, or for some other pre-selected time range. After that timerange passed, the electricity may be stopped for at least a briefduration of time.

In some embodiments, one or more visual stimulation devices 5 c can beconnected to at least one of the electricity transmitter 1 g and/or thefirst transceiver unit 1 c and/or the second transceiver unit if suchthat the computer device can communicate with the one or more visualstimulation devices 5 c and/or transmit electricity to visualstimulation mechanisms 53 of that device to provide power for providinga visual stimulus to a patient. Such a stimulation may be activation oflights in a patient's left eye, right eye, or both eyes. The visualstimulation may occur at the same time in both eyes and/or at differenttimes for different eyes. Each visual stimulation mechanism 53 mayinclude, for example, light emitting diodes or other type of lightemitting devices. These light emitting devices may be positioned inglasses, goggles, a helmet having a visor, or other type of headgearthat may be positioned on a patient's head to position the visualstimulation mechanism near the patient's eyes to provide the visualstimulus to the patient. The one or more visual stimulation devices 5 ccan be used as an alternative to evoked electrodes 5 a and 5 b or may beused in combination with those evoked electrodes to provide stimulus toa patient to measure how the patient's body reacts to that stimulus forpurposes of evaluating at least one neurological condition of thepatient.

In some embodiments, the device may be configured to take measurementsvia at least one of the sensors to measure the amount of power requiredto stimulate a patient at a specified current. The device can beconfigured to receive such measurement data from one or more of thesensors to determine skin impedance, placement orientation issues and/orsweat levels of the patient. In the event a placement orientation issueis detected, the device can be configured to cause a warning to beemitted to having the electrodes re-positioned to be correctlypositioned by a user. The device can also be configured to calibrateother measurement data it receives from the sensors based on the skinimpedance and/or sweat level measurement data.

In some embodiments, more than two evoked electrodes may be used. Forexample, there may be more than two evoked electrodes, more than fourevoked electrodes, or more than six evoked electrodes. In yet otherembodiments, only two evoked electrodes may be used.

A plurality of sensors can also be connected to the processor unit 1 a.The sensors can include a first sensor 3 a, a second sensor 3 b, and athird sensor 3 c. The sensors may also include additional sensors (e.g.a fourth sensor, a fifth sensor, a sixth sensor, etc.). In someembodiments, the sensors may be configured as electrodes or includeelectrodes such as electroencephalogram (EEG) electrodes and/orelectrocardiogram (also referred to as “ECG” or “EKG”) electrodes. Inother embodiments, the sensors may include other types of electrodesthat may be placed on a patient's head and/or neck to detect theresponse to the evoked potentials in the patient's brain and/or evokedpotentials of a patient's head and neck. The first sensor 3 a can beconfigured for being positioned on a left side of a patient's head orneck and the second sensor 3 b can be configured for being positioned ona right side of the patient's head or neck (e.g. a side of the patient'shead or neck that is opposite the side of the patient's head or neck towhich the first sensor 3 a is positioned). For instance, in someembodiments the first sensor 3 a may be positioned on the left side ofthe patient's head, the left side of the patient's head behind thepatient's left ear, or on the left side of the patient's forehead or onthe left side of the patient's neck. The second sensor 3 b can bepositioned on the right side of the patient's head, the right side ofthe patient's head behind the patient's right ear, on the right side ofthe patient's forehead or on the right side of the patient's neck.

The sensors can be configured and/or positioned to detect the patient'sbrain reaction to the evoked potential transmitted to the patient'snervous system via the evoked electrodes. For instance, the sensors canbe positioned and/or configured to detect the patient's brain'sreactivity to the evoked potential. For instance, the sensor can detectand/or measure the reaction of the patient's somatosensory cortex,associated sensory cortex, medial lemniscus and/or the thalamus to theevoked potential transmitted to the patient's body via the evokedelectrodes.

The third sensor 3 c can be configured as a reference sensor and may bepositioned anywhere on the patient's body. In some embodiments, thethird sensor may be positioned between the first and second sensors 3 a,3 b to provide a more reliable reference signal as compared to otherlocations. For instance, the third sensor 3 c may be positioned on ornear the center of the patient's forehead, the top of the patient'shead, the center of the back or front of the patient's neck (e.g.between the first and second cervical vertebrae), or other location onthe patient's body. In some embodiments, the third sensor 3 c can bepositioned an equidistant distance from the first and second sensors 3a, 3 b. In other embodiments, the third sensor 3 c can be configured tobe positioned less specifically between the first and second sensors 3a, 3 b so that the precision of placement of the third sensor 3 cbetween the first and second sensors 3 a, 3 b is not necessary.

In some contemplated embodiments, the first sensor 3 a can be positionedon a left side of a patient and the second sensor 3 b can be positionedon the right side of the patient and be configured to function as areference to eliminate the need for a third reference sensor.

Embodiments of the stroke detection device can be utilized in methods oftreating patients. For instance, the stroke detection device can be usedby medics (e.g. EMS personnel, EMT personnel, paramedics, etc.), duringemergency care situations. FIG. 2 illustrates one example of such amethod.

In some embodiments of the method, medics may travel to a location inwhich a patient needs help in a vehicle such as an ambulance, a truck, avan, or a car. Once at the location, a medic may find the patient whoneeds help, such as providing some type of care to the patient at thelocation. The medic may also transport the patient to a hospital toreceive care in a facility having certain equipment needed to providemore substantial care to treat a problem affecting the patient. As partof treating that patient prior to delivering the patient to a hospital,the medic may place evoked electrodes on the wrists, ankles or behindthe knees of the patient (e.g. place first and second evoked electrodes5 a and 5 b and any other additional evoked electrodes (e.g. thirdevoked electrode on right side of patient body, fourth evoked electrodeon left side of patient's body, etc.) on the patient). For instance, thefirst evoked electrode 5 a can be positioned on the patient's rightwrist, right ankle, or behind the patient's right knee and the secondelectrode 5 b can be positioned on the patient's left wrist, left ankle,or behind the patient's left knee. This may be accomplished by use ofstraps that have interconnectable end portions together. For example,each of the evoked electrodes may be attached to a strap having aplurality of hooks on one end portion and a plurality of loops on anopposite ends for releasably connecting the end portions together toform a ring or annular shaped strap that is sufficient to encircle apatient's wrist, ankle, or leg to position the evoked electrode incontact with the skin of the patient at such a location. It iscontemplated that a type of adhesive material or a gel could also beapplied between the electrode and the patient's skin by the medic tofacilitate adhesion and/or positioning of the evoked electrode on thepatient and/or efficient functioning of the evoked electrode when usedon the patient.

The medic may also position the first, second, and third sensors 3 a, 3b, and 3 c and/or any other sensors of the stroke detection device on tothe patient's body. For instance, the medic may position the firstsensor 3 a on the right side of the patient's forehead, behind the rightear of the patient, or on the right side of the neck of the patient. Themedic may position the second sensor 3 b on the left side of thepatient's forehead, behind the left ear of the patient, or on the leftside of the neck of the patient. The third sensor 3 c may then bepositioned on the patient between the first and second sensors 3 a, 3 b,such as in the middle of the patient's forehead, on the back of thepatient's neck, or on the top of the patient's head. For someembodiments having more than three sensors, these additional sensors mayalso be positioned on the patient.

In some embodiments of the method, the first, second, and third sensors(and any other additional sensors) may be attached to a headband elementor a strap that may be positioned around a patient's head so that thefirst, second, and third sensors 3 a-3 c are all positioned at the sametime when the headband, helmet, or other type of head gear is positionedon the patient. As another alternative, an adjustable collar that may beadjustably tightened around a user's head or neck can be positioned onthe user to position the first, second, and third sensors (and anyadditional sensors) on the patient at the same time. Adhesive, a gel, orother type of material may be placed on each sensor to help position thesensor on the patient at a desired location. For example, each sensormay be included in a patch having an adhesive on it so that each sensormay be positioned in contact with a patient's skin at a desiredlocation. For embodiments in which the sensors are included in a type ofgarment that can be worn by a patient, the headband, a helmet, a collar,or other type of garment or headgear that may include one or more of thesensors can also include such patches or other type of adhesive tofacilitate positioning of the sensors.

The evoked electrodes and sensors may be placed on the patient in anyparticular order or arrangement as desired by at least one medic. Forinstance, the sensors may all be positioned before or after the evokedelectrodes are positions. As another example, the sensors may bepositioned after at least some of the evoked electrodes are positionedon the patient or the sensors and evoked electrodes may be positioned onthe patient at the same time by multiple medics or only one medic.

The medic may position the evoked electrodes and sensors on the patientprior to placing the patient in an ambulance or other vehicle.Alternatively, the medic may wait until the patient is in an ambulanceor other vehicle before positioning the electrodes and/or sensors. Asyet another alternative, some of the sensors and/or electrodes may beplaced on the patient before the patient is placed in a vehicle andothers may be positioned after the patient is positioned in the vehiclefor transport to a hospital or other type of care facility.

An exemplary embodiment of evoked electrodes and sensors that may beprovided in a kit with an embodiment of the neurological condition unitis shown in FIG. 6. The evoked electrodes and sensors may be provided ina kit form that includes a plate or paper having instructions forpositioning of the evoked electrodes and sensors. The kit can beconfigured to include the instructions, sensors, and evoked electrodesin a single plastic bag that contains these elements of the kit. Thesingle bag may be a sealed vacuum bag that is sealed after the elementsof the kit are positioned in the bag. The evoked electrodes and sensorsmay be positioned on pads or other structure that is adhesively coupledto the member having the instructions or is frangibly positioned on thatmember so that these elements may be peeled from the member or brokenoff from the member for placement on a patient for a one-time only useof the electrodes and sensors. After the electrodes and sensors are usedon a patient and these elements may be thrown away and a new kit havingthe same elements can be used for a new patient. As an alternative, theelements of a kit may be re-used for multiple patients instead of beingdesigned for use as a one-time only use.

The kit may include, for example, left and right evoked electrode pads17 (e.g. first and second pads each connected to at least one evokedelectrode) for being adhesively attached to the skin of a patient nearthe patient's right wrist and left wrist. A removable covering 18 can bepositioned on the side of each pad having the adhesive to cover theadhesive so that the pad is only attachable near a patient's wrist afterthe covering 18 is removed to expose the adhesive layer on the pad 17.Indicia providing instructions on where each pad should be positioned ona patient can also be included on the covering 18 and/or on otherinstructions 23 provided with the kit, such as instructions placed on aplate or other member to which the pads 17 of the kit may be removablyattachable. The instructions can include one or more schematics ordrawings to illustrate how each pad should be positioned on a patient.

At least two pads 17 can each include at least one respective evokedelectrode (e.g. first evoked electrode 5 a or second evoked electrode 5b). One or more fourth sensors 3 d can also be included in each pad. Theone or more fourth sensors 3 d can include an accelerometer, atemperature sensor that measures the temperature of the patient, a lightemitting diode (LED) sensor for detecting skin color and/or skinfriability, a positional sensor and/or a perspiration sensor. A LED thatis configured to blink the light of the light emitting diode or keepthat light on in response to a determination that the pad is incorrectlypositioned on a patient can also be included. The positioningdetermination can be made based on a detection made by a fourth sensorthat is connected to the light emitting diode. For instance, the one ormore fourth sensors can include a positional sensor that detects thedistance that sensor is from another positional sensor of another padhaving an evoked electrode so that when the detected distance is smallerthan a pre-selected threshold, the light of the light emitting diode isactivated to blink or stay on to indicate the position of the evokedelectrodes provided via the pads is not correct. The positional sensorcan also send data to the computer device to identify the incorrectpositioning of evoked electrodes so that the computer device can usethat information to control for latency that may exist in themeasurement results due to the misplacement of the evoked electrodes.The perspiration sensor can be configured to provide measurement data tothe computer device to detect sweat from the patient for use incalibrating the measurement results received from other sensors.

The light emitting diode (LED) sensor for detecting skin color and/orskin friability can be configured to provide measurement data to thecomputer device 1 to provide initial inputs for the age and race of apatient. That measurement data can be overwritten by input provided by auser who may enter the age and race of the patient via an input deviceas the user entered data could be more accurate than the LED sensordata. But, if no such user input is provided, the LED sensor data can beused to help improve the accuracy of the device as it assessesmeasurement data received from the sensors for use in assessing thepatient's condition.

The light emitting diode (LED) sensor for detecting skin color and/orskin friability that may be one of the one or more fourth sensors 3 dcan be configured so that the sensor includes an LED that may use eitherinfrared or non-infrared light that is paired with a photodiode. Thephotodiode may be configured to measure the light emitted from the LEDthat is reflected off of a patient's skin back to the photodiode that ispositioned on the pad 17 or other element that is used to position theLED sensor on the patient. The amount of light measured to have beenreflected back to the photodiode can be measured as light that was notabsorbed or scattered by the patient's skin. This measurement data canbe used to reference ranges of data stored in memory of the computerdevice that identifies the skin color of the patient. For instance, ifthe measurement data is within a first range that is identified ascorresponding to Caucasian or white, the computer device may beconfigured to receive the measurement data of the fourth sensor anddetermine that the patient is Caucasian or white. If the measurementdata is within a second range that is identified as corresponding toAfrican American or black, the computer device may be configured toreceive the measurement data of the fourth sensor and determine that thepatient is African American or black. If the measurement data is withina third range that is identified as corresponding to Asian or Indian,the computer device may be configured to receive the measurement data ofthe fourth sensor and determine that the patient is Asian or Indian.

The same measurement data from the photodiode may also be compared toother stored data that corresponds to age ranges for a patient so thatthe computer device can be configured to estimate an age of the patientbased on the fourth sensor measurement data. For instance, if themeasurement data is within a first range that is identified ascorresponding to 40-50 years old, the computer device may be configuredto receive the measurement data of the fourth sensor and determine thatthe patient is 40-50 years old. If the measurement data is within asecond range that is identified as corresponding to a patient having anage of 50-60 years old, the computer device may be configured to receivethe measurement data of the fourth sensor and determine that the patientis 50-60 years old. If the measurement data is within a third range thatis identified as corresponding to 60-70 years old, the computer devicemay be configured to receive the measurement data of the fourth sensorand determine that the patient is 60-70 years old.

In some embodiments, it is contemplated that the pre-selectedmeasurement ranges may be stored in non-transitory memory of thecomputer device or memory that is accessible to the computer device sothat the pre-selected ranges are based on age and race such that themeasurement data can be used to determines both age and race of apatient by comparison of that data to this single set of stored age andrace range data. As another alternative, the pre-selected age and raceranges may be stored as separate sets of data so that the samemeasurement data is used to identify the age based on pre-selected andsaved first set of age data ranges and also used to identify race basedon a different second set of pre-selected and saved race related rangedata

If an accelerometer is included as sensor of the pad 17, theaccelerometer may be configured to send measurement data to the computerdevice 1 to provide a feedback loop for electric current delivered forstimulation to the patient via the one or more evoked electrodes of thatpad. The electric current and/or voltage may be continued to beincreased for each shock to a patient provided via an evoked electrodeuntil the accelerometer detects a movement of a patient's wrist or armto which the pad 17 is attached that is at or beyond a pre-selectedthreshold (e.g. acceleration, velocity, and/or distance theaccelerometer moved relative to a pre-selected threshold such as amovement of 10 cm, movement of 5 cm, movement of 2 cm, movement of 10-2mm, etc.). The measurement data that identifies the amount of a movementof the patient's hand or arm measured by the accelerometer can also beused by the computer device to correlate how much power was induced viathe evoked electrodes into the patient to provide a shock to thepatient. Such data can also be used by the computer device to determinewhether that evoked electrode is properly positioned on the patient'sbody.

The measurement data from the accelerometer sensor, which can be one ofthe one or more fourth sensors 3 d, can also be used by the computerdevice to determine a level of noise that may be included in thepatient's shock response measurement data from motion of the patientand/or to determine whether an evoked electrode of the pad or other bodywearing element to which that accelerometer is attached is properlypositioned. For instance, motion of a patient above a set threshold maybe correlated with a pre-selected and saved noise error correctionfactor data set stored in the memory of the computer device. Theaccelerometer measurement data may be used by the computer device tocompare that data to the noise error data so that a noise errorcorrective factor is selected for evaluating other sensor measurementdata based on a noise error associated with detected motion of thepatient. Alternatively, the computer device may be configured to not useany measurement data that is collected from a patient's response to oneor more shocks when the accelerometer measurement data indicates thepatient was moving during the testing of the patient so that data is notutilized by the computer device to detect a patient's condition that maybe too error-prone to allow for an accurate determination of thepatient's neurological condition.

A third pad 17 can also be connected to first, second, and third sensors3 a, 3 b, and 3 c for positioning on a patient. For example, the thirdpad can have a covering 18 over an adhesive portion of the pad that isremovable to facilitate adhesive attachment of the third pad to the backof a patient's neck, forehead of a patient, or other portion of apatient's body. In embodiments where the pads are attached to a memberin a bag of the kit, the covering 18 may be a portion of the member towhich the pad is removably attached. The third pad can also include aninfrared sensor that is configured to measure oxygen content of theblood near the surface of the patient's skull. Alternatively, a fourthpad can be provided that has such an oxygen content sensor.

The first, second, and third sensors as well as any fourth sensors 3 dcan each be configured as electrodes or other type of sensor that isable to convert a measurement signal from analog to digital data andsubsequently wirelessly transmit the converted digital measurement datato the computer device 1 via a wireless communication link (e.g.Bluetooth, etc.). In other embodiments, the sensors may be wired to thecomputer device 1 to provide the communication connection.

In some embodiments of the kit, pads 17 to which evoked electrodes areattached may be sewn into gloves so that each glove has at least one pad17 having one or more evoked electrodes and at least one fourth sensor 3d. Each glove can be configured to cover a patient's hand and extend upthe patient's forearm to a desired stimulation site at which the pad 17of the glove is positioned when the glove is worn by a patient. Eachglove can have a line defined therein or drawn thereon, printed thereon,or otherwise demarcated thereon so that a medic could determine byreferencing that line whether the glove was twisted when it was put onthe patient. If the glove was determined to be twisted by referencingthat line of the glove, the medic could readjust the glove to preventsuch twisting to avoid the twisting providing less accurate results. Forexample, if one glove was twisted sufficiently while the other glove wasnot twisted, the left and right stimulation amplitudes could differ dueto that twisting, which could result in inaccurate responses measured bythe first and second sensors 3 a and 3 b. A stretch center sewn into theglove can be used to help a user detect twisting and help prevent suchinaccurate measurements by untwisting any twisted glove before thedevice evokes response from a patient or measures those responses.

In other embodiments of the kit, pads 17 to which evoked electrodes areattached may be sewn into or otherwise incorporated into arm bands sothat each arm band has at least one pad 17 having one or more evokedelectrodes and at least one fourth sensor 3 d. For instance, each armband may be an annular shaped pad 17 that is made of an elastomericmaterial that has an inner channel through which a patient's arm can bepassed so that the user may wear the arm band on the user's forearm. Theelastomeric material of the arm band can be configured to ensure theannular shaped pad 17 is tightly and/or compressively fit against thepatient's arm so that the evoked electrode and one or more fourthsensors of the arm band are positioned on the patient's skin of thepatient's forearm or otherwise in sufficient engagement with thepatient's skin of the patient's forearm. Embodiments of the arm band forthe pads 17 can be configured to include a marking or other indicia(e.g. a centerline or other type of indicia) that can be configured toindicate to a medic or other type of care provider that the arm band isbeing worn by a patient correctly for the sending of shocks to thepatient via the one or more evoked electrodes of that armband and forthe one or more fourth sensors 3 d to be able to accurately measure datarelating to the patient's responses to those shocks. The indicia can beconfigured to allow for a visual inspection to verify the arm bands arebeing worn on the right and left arms of a patient correctly before thecomputer device is used to assess a condition of the patient to helpensure the results of the conducted assessment are accurate.

After the sensors and evoked electrodes and sensors are positioned onthe patient via the pads 17 (e.g. pads adhesively attachable to apatient, arm bands, gloves, etc.) or other positioning mechanisms, thecomputer device may be activated and/or input may be provided to thecomputer device 1 to initiate monitoring of the patient's condition todetect whether the patient has experienced a stroke, is experiencing astroke, or may be about to experience a stroke. An electrical currentcan be periodically transmitted to the patient via the evoked electrodes(e.g. first and second evoked electrodes 5 a, 5 b and/or any additionalevoked electrodes that may be included in a particular embodiment). Forinstance, the electrodes may transmit a current of 5 mA, a current ofover 50 mA, a current of between 50 mA and 200 mA, a current not greaterthan 200 mA, or another current within a pre-selected value range or ata pre-selected value, to the left and right sides of the patient via thefirst and second evoked electrodes 5 a, 5 b to evoke a response to thiscurrent from the nerves of the patient. The current may “shock” thepatient and may be transmitted for a first pre-selected period of timesuch as for less than 1 second, less than 0.5 seconds, less than 0.25seconds, or other pre-defined time period. Multiple “shocks” may beprovided to the patient within a given time period. For instance, thepatient may experience 2-3 evoked potential events (e.g. shocks), 2-5evoked potential events (e.g. shocks), 4-5 evoked potential events, ormore than five evoked potential events (e.g. shocks), each second byreceiving the current for the pre-selected time period multiple timeswithin a second. After each evoked potential event (e.g. shock), thecurrent may cease being transmitted to the patient for a secondpre-selected time period before the next evoked potential event (e.g.shock) is applied to the patient via the evoked electrodes andelectricity transmitter unit 1 g.

The evoked electrodes may alternatively be replaced by or supplementedwith other stimulating evoked electrodes or other modalities connectedto the computer device for actuation of visual stimulus to be providedto a patient. For instance, modalities can be configured to provide avisual evoked potential to a patient. An example of such modalities aremay be one or more light emitting devices or other type of visualstimulation mechanisms 53 that provide visual stimulation to a patientvia a form factor of a portable light. For instance, instead of pads, oran armband, a head wearable device 51 such as a headband, goggles,glasses, or another type of headgear can be worn by a user and haveevoked electrodes that are configured to provide visual stimulation tothe left and right eyes of a patient. The evoked potential may providevisual stimuli to a patient via flashing of light of a sufficientquality to stimulate a patient sufficiently to evaluate the patient'sneurological condition from the patient's response to the visualstimulus. The flashing light may be the stimulus provided to the patientvia these visual stimulation mechanisms 53. The computer device can beconfigured to provide power to the visual stimulation mechanisms 53 sothat the duration and brightness of the light emitted to evoke aresponse from the patient is provided to the patient to provide apre-selected number of visual stimuli to the patient within apre-selected time period. These visual stimuli can be provided as analternative to electrical shocks or may be provided in combination withthe electrical shocks via other evoked electrodes (e.g. evokedelectrodes positioned by wrists of a user wearing arm bands, gloves, orpads having such evoked electrodes, etc.).

The neural signals of the patient's brain (e.g. the electricalpotentials of the patient's brain or the biosignals of the patient'sbrain) may be read by the computer device by use of the sensors todetermine whether there is an asymmetric pathology. For instance, ifthere is determined to be an asymmetric pathology such that one side ofthe patient's brain (e.g. the right side or left side of the patient'sbrain) has a substantially different somatosensory evoked potential(SEP) as compared to the opposite side of the patient's brain (e.g. theother side of the right or left side of the patient's brain), then thecomputer device 1 may be configured to generate an alert to communicatethe alert to the medic to identify the detected stroke condition to themedic via one or more output devices and/or input/output devices. Ifthere is no difference in SEP response or a difference is not outside ofa pre-selected threshold range, then the computer device 1 may beconfigured so that a stroke event is not detected and no such alert maybe provided.

It is also contemplated that the computer device can be configured sothat motor evoked potential, sound/aural evoked potential and/or visualevoked potential are also utilized by the computer device to determinewhether an asymmetric pathology may be present in a patient. Forinstance, different devices, input/output devices, sensors and/ordetectors may be connected to the device to transmit motor evokedpotential, sound/aural evoked potential and/or visual evoked potentialfor use in evaluating the patient's response to these evoked events.

In other embodiments of the method, the stroke detection device can beconfigured for use in urgent care facilities, general practitionerdoctor offices, nursing homes or assisted living environments in whichnursing staff or other staff members having a limited amount of medicaltraining may use the device to help them detect whether a particularperson in the care of that facility has experienced a stroke or isundergoing a stroke. To perform such monitoring or detection, the staffpersonnel may position the evoked electrodes and sensors, connect thoseevoked electrodes and sensors to the stroke detection device, andthereafter run the device to monitor the condition of the person undertheir care.

Embodiments of the stroke detection device can be configured to collectdata from the patient and perform the comparison of SEP data obtainedfrom the patient from the right and left sides of the patient's body indifferent ways. FIGS. 3 and 4 illustrate one exemplary comparison methodthat may be utilized by the computer device 1. An application 1 d storedin the memory 1 b of the computer device may define the method to beperformed by the computer device 1 by a processor executing the code ofthe application 1 d to perform this comparison.

The code of the application can be stored in both the device and acentral communication server having a processor, non-transitory memory,and at least one transceiver unit that is communicatively connectable tothe computer device 1. The code can be updated at the centralcommunication server and this update may subsequently be communicated tothe computer device via a network connection (e.g. an internetconnection, a cellular network connection, a local area networkconnection, a wide area network connection, etc.). The centralcommunication server may also be configured to receive data fromdifferent devices 1 to use that data to optimize the code of theapplication so that the application can provide improved performanceafter being updated. The updates to the application code made at thecentral communication server can be periodically transmitted to each ofthe devices that may be employed in different environments so that thedevices may update the code for the applications stored in their memoryfor updating of their applications and improving the performance of thedevices 1.

Referring to FIG. 4, the computer device 1 may be configured to beginproviding shock treatments, or evoked potential, to the patient afterreceiving input to initiate stroke detection and/or monitoring for thepatient. Such an initiation may occur when the medic selects a button ona graphical user interface displayed to the medic on a display device toprovide such input to the computer device. As another example, suchinitiation of stroke detection and/or stroke monitoring may occur whenthe computer device 1 detects that the evoked electrodes and sensors arepositioned on a patient's body.

An evoked potential may then be transmitted to the patient via theelectricity transmitter unit 1 g and the evoked electrodes so that theleft and right sides of the patient's body near corresponding left andright side nerves of the patient's body each receive the same amount ofcurrent for the same amount of time (e.g. current of 5 mA for less than0.5 seconds or current of no greater than 200 mA for less than 0.75 or0.25 seconds, etc.) The sensors can collect data from the patient's bodyat the locations in which the sensors are positioned to collect dataabout the sensory evoked potential that is generated by the patient'sbody in response to the evoked potential (e.g. each shock). Thatcollected data is transmitted to the memory 1 b of the computer devicevia the transceiver unit 1 c and/or processor unit 1 a of the computerdevice 1 for saving in a data store 1 e. The data is collected over atleast the first pre-selected time period. This time period may beconsidered a third preselected time period in some embodiments. Thethird pre-selected time period may only include time within the firstpre-selected time period and/or the second pre-selected time period. Forinstance, the third pre-selected time period may include a portion ofthe first pre-selected time period or the entirety of the firstpre-selected time period in which the patient's body is experiencing theevoked potential and may also include additional time that may extendinto the second pre-selected time period in which the event potential isnot being transmitted into the patient's body (e.g. the thirdpre-selected time period may include time in which the patient is beingshocked and may also include time in which the patient has ceased beingshocked).

If the number of samples of data collected from the patient is not overa pre-selected threshold value, then the computer device may beconfigured to cause the electricity transmitter unit 1 g to emitelectrical current to the evoked electrodes for the first pre-selectedtime period again and then cease the providing of that current to thepatient for the second pre-selected time period so that additional datacan be collected by the sensors. The samples of collected data receivedfrom the first, second, and third sensors 3 a-3 c may be stored in thememory of the computer device 1. In some embodiments, the samples ofcollected data received by the sensors may be averaged or otherwisemanipulated by the processor unit 1 a prior to storing that data in adata store 1 e in the memory 1 b. This process of providing evokedpotential (e.g. a shock) at separated time intervals by the computerdevice 1 to collect and store data for assessing the condition of thepatient may be repeated until the data that is collected from thesensors 3 a-3 c is over a threshold value for samples of data.

In some embodiments, the computer device 1 can be configured so thatbetween 128 and 256 samples of SEP data can be collected from thepatient. Other embodiments may be configured to collect more samples ofdata per second or less samples of data from the patient before making adetermination on whether the patient may have undergone a stroke or isexperiencing a stroke.

The data that is received from each sensor may be stored in a table orother type of database or data store. The data from the first sensor,second sensor, and third sensor may each be assigned to a respectivecolumn of a table or otherwise grouped so that data from each sensor isgrouped separately from data from the other sensors to facilitate thecomparison of data from the different sensors. After sufficient data hasbeen collected from the patient, the data from the first sensor 3 a canbe compared to the data collected from the second sensor 3 b located onan opposite side of the patient's body from the first sensor 3 a. Anexample of how that data may be compared is shown in FIG. 3.

For example, patient left side signal data can be filtered and thepatient's right side signal data can also be filtered. The filtration ofthese data signals may be performed using the same type of filtrationmethodology. The filtration of the data may be configured to removenoise from the collected data that may be present due to the electrodesor other type of possible interference in the data. After filtration,one of the sets of data can be inverted for purposes of comparing to theother set of data. For instance, the patient's right side signal datacan be inverted for comparing to the uninverted filtered patient leftside signal data. In other embodiments, the patient left side signaldata can be inverted for comparing to the uninverted filtered patientright side signal data. An absolute value of a difference between theright and left side signal data is then determined. Such an absolutedifference may identify a difference in disregard of whether thedifference is a positive or negative numerical value (e.g. −5 and +5 aretreated the same way). If the difference between the right and left sidepatient signal data is below a threshold value, the computer device 1can be configured to determine that the patient has not undergone astroke or is not undergoing a stroke so that no stroke alert isgenerated to communicate a warning to the medic. If the differencebetween the right and left side patient signal data is at or over thethreshold value, the computer device can be configured to determine thatthe patient has undergone a stroke.

Noise levels can be used by the device to determine a test length forthe patient. First and second sensor 3 a and 3 b can be positioned onthe patient prior to providing any stimulation (e.g. shocks/evokedpotentials etc.) to the patient to provide measurement data to thedevice 1 that the device can save and subsequently use to approximatenoise levels in the patient's current environment. That data can be usedby the device to estimate how many samples it will need to correctlydiagnose a neurological condition of the patient and adapt the number ofsamples to be taken from the patient based on the determined noiselevel. The number of samples that are needed can be combined with thestimulation rate to communicate to a user via an output device how longthe testing of the patient (e.g. evaluation of the patient to beperformed by the device) will take prior to the device beginning toinitiate stimulation to the patient via the evoked electrodes.

In some embodiments, noise levels can be measured via sensor data sothat the computer device is able to determine a baseline noiseenvironment level prior to performing an evaluation of the patient viathe shocking or other stimulation of the patient via evoked electrodes.The sensor can provide measurement data used to determine theelectromagnetic (EM) noise levels in different environments as well asother noise measurements (e.g. accelerometer related noise concerningpatient motion, etc.). The measurement data obtained prior to thetesting of the patient can be used by the computer device to performdynamic environmental filtering so that filters are automaticallyapplied to the measurement data received during testing of a patient inwhich the patient's responses to shocks are collected from the sensorsand subsequently evaluated by the computer device. In some embodiments,one of multiple different pre-selected measurement data evaluationfunctions may be utilized by a processor of the computer device toperform the analysis of the received measurement data based on the priordetermination of the noise level that was determined to exist prior tothe testing being started.

For instance, in some embodiments, the data collected from the sensorscan be used to generate a wave form or a curve that identifies aresponse to an SEP of the patient based on the data collected from eachsensor. In some embodiments, the wave form or curve can be formed basedon electroencephalography (EEG) or electrocorticography (ECoG)principles. Each wave form or curve for corresponding time periodsbetween the first and second sensors 3 a, 3 b can be compared to eachother to determine a difference between the amplitude positions of thewave forms at corresponding times (e.g. the difference in amplitude of asignal from the right side of the patient's body as compared to the leftside of the patient's body at the same time at which the data wasrecorded) or evaluate other morphological features of measurement dataof the response of the user to the shocks or other stimulation that maybe provided via evoked electrodes. If the difference in amplitudepositions is greater than or equal to a pre-selected threshold value,then the computer device can be configured to detect the patient ashaving experienced a stroke or undergoing a stroke for generation of astroke alert for communicating the stroke alert to a medic.

To perform the comparison of the patient's left and right side signals,the application 1 d can define a pattern recognition methodology used bythe processor to evaluate the stored data collected from the sensors, apeak detection methodology used to detect a peak of a waveform of a EEGsignal for the data obtained from the sensors 3 a-3 c, and an amplitudecomparator methodology for comparing the absolute differences inamplitude that may exist for that data collected from each sensor. Thismethodology may incorporate a wave construction technique that isconfigured to provide wave sorting or spike sorting to differentiatedifferent waves to avoid wave conglomeration to improve the accuracy ofthe amplitude comparisons being made by the computer device. Theapplication can also be configured so that latency that may exist fordata from one sensor as compared to other sensors can be accounted fordue to the patient's body structure and/or due to the functioning of theelectrical communicative components of the stroke detection device.

For instance, in some embodiments the computer device can be configuredto perform an evaluation of the measurement data it receives from thesensors. The evaluation of the measurement data can include anevaluation and/or comparison of the subcortical to cortical ratio of themeasurement data for the responses of the left and right sides of thebody, an evaluation and/or comparison of the absolute amplitudes of themeasurement data for the responses of the left and right sides of thebody, the first and second derivatives of the measurement data for theresponses of the left and right sides of the body, the N35 component ofthe measurement data for the responses of the left and right sides ofthe body, the absolute latency of the measurement data for the responsesof the left and right sides of the body, the amplitude ratio of themeasurement data for the responses of the left and right sides of thebody, and/or the interpeak latency of the measurement data for theresponses of the left and right sides of the body.

The application 1 d can also define how demographic factors or dynamicaveraging of measurement data should be performed by the computer devicerunning the application. For instance, input relating to demographicfactors that can affect how measurement data from the sensors isevaluated can include sex, age, race, height, and skin impedance of apatient. Such data may be provided by sensors (e.g. one or more fourthsensors 3 d or other sensors) or by a user providing input via an inputdevice that identified an age, sex, race, skin color, or other datarelating to such demographic factors for storage in the memory of thecomputer device for use during testing of a patient.

In some embodiments, a neck recording electrode (e.g. at least onesensor positioned on a patient's neck via a pad or neck band, etc.) canbe configured to allow the computer device to control for a misplacementof one or more evoked electrodes. For example, if a right evokedelectrode is placed correctly, but a left evoked electrode is positioned3 centimeters away from its correct placement, the computer device 1 canbe configured to correct the measurement data for the misplacedelectrode to automatically account for this incorrect positioning.Alternatively, the computer device can be configured to transmit awarning to a user to provide information to the user to adjust theposition of the incorrectly positioned evoked electrode. Such anevaluation may be performed via one or more sensors on a patients neckthat measure the signals received by the right and left sides of thebody in response to shock events or other stimulations. The latency ofthe measurements received by the right side can be compared to the leftside data via the neck sensor measurement data. When one side of thebody is determined to have a latency that is beyond a pre-selectedthreshold, this can indicate that one of the evoked electrodes isincorrectly positioned. The use of the neck sensor(s) to account forincorrect positioning of one or more evoked electrodes can permit thecomputer device to avoid making incorrect evaluations due to incorrectplacement of the evoked electrodes on a patient.

It is contemplated that neural networks and/or evolutionary selectionalgorithms and artificial neural networks can be used to generate binaryclassification functions and/or other discriminant classificationpatterns for different races, gender, age, height, and baseline noiseenvironments. Such features can permit the computer device to test apatient and account for the demographics of a patient and noiseenvironment of a patient to improve the reliability and accuracy of thecomputer device's testing of a patient's neurological condition andevaluation of measurement data obtained via that testing.

The computer device can also be configured to utilize dynamic averagingof measurement data based on various factors, such as the noiseconditions present during a test of a particular patient. The computerdevice can be configured so that the number of shocks utilized tomeasure patient responses to the shocks is dynamically determined toprovide a sufficient number of samples (e.g. each shock and responsebeing a separate sample) to evaluate a patient given various applicableconditions that could affect that testing. For example, in some lowbackground noise environments, only 10-20 stimulations (or samples) maybe used to obtain sufficient measurement data for storage and evaluationby the computer device for assessing a condition of a patient while in ahigh noise environment up to 500 stimulations (or samples) may be takento obtain sufficient measurement data for storage and evaluation by thecomputer device for assessing a condition of a patient.

In evaluation of measurement data, the measurement data may be evaluatedby the computer device to identify various different types ofmorphological features based on the measurement data received from thesensors. For example, peak amplitude, power, latency, slope, and othermorphological features of the measurement data for the patient'sresponse(s) to the stimuli for each sample may be identified andassessed. These morphological characteristics of the measurement datamay covary with each other. Morphological covariation of the data can beperformed by the computer device to estimate locations of sensorplacement on the patient to identify faulty testing that may provide inan unreliable result that should not be used. Upon such a determinationbeing made, a warning may be communicated via an output device to a userso that the patient can be retested after the sensor positions andevoked electrode positions are rechecked to ensure they are correctlypositioned on the patient.

For instance, in some embodiments, the computer device can be configuredso that when a variance of two or more morphological characteristics arefar removed from the known covariance of those characteristics, theconducted test is interpreted as invalid and a warning is issued to theuser via an output device. For example, if an amplitude of a peak isknown to vary with slop of another peak by a first factor and a firststandard deviation in a given test and the variance between these twofactors exceeds a pre-selected covariance threshold, then the test canbe determined to be invalid by the computer device.

The third sensor 3 c may be positioned for providing a reference signal.The reference signal data can be used to filter out artifacts created bythe body and/or environment.

The stroke detection device can be positioned in an ambulance such as anambulatory truck, van, bus, helicopter, boat, airplane, or other type ofvehicle used by medics to transport patients. In some embodiments, it iscontemplated that the computer device 1 can also be configured tocommunicate the data collected from a patient to a computer system ofthe hospital to which the patient is delivered so that the collecteddata can be used by medical staff of that hospital when treating thepatient. For instance, the computer device 1 may be configured totransmit the collected data to a hospital communication device 13.

The computer device 1 can also be configured to analyze the sensor datareceived from the sensors positioned on the patient to differentiatebetween whether a detected condition is due to a hemorrhagic burstand/or an ischemic artery block for one or more identified arteries and,for each artery determined to be blocked, estimate or otherwisedetermine an extent to which each identified blocked artery is blocked(e.g. fully blocked, 90% blocked, 75% blocked, etc.). For instance, thedevice can be configured so that amplitudes in measurement data from atleast one of the sensors is below a pre-selected threshold, a hemorrhagemay be detected. In the event major peaks are determined to exist in theamplitudes of the measurement data that are sufficiently below thatpre-selected threshold the device may be configured to detect anischemic artery block and estimate the degree of blockage based on theamplitude levels of the sensor measurement data. In some embodiments,the measurement of the amount of diffusion due to hemorrhagic stroke byuse of a far field effects can be used. An abnormal attenuation ofsignal between two or more points on the brain from such measurement canbe indicative of a hemorrhagic stroke and the computer device can beconfigured to identify such an occurrence via sensors providingmeasurement data providing data that indicates such an occurrenceexists. This information can also be communicated to the hospitalcommunication device 13 to help facilitate the providing of care to thepatient when the patient is delivered to the hospital.

The computer device can also be configured to communicate with alocation service. For instance, the computer device 1 may be configuredto communicate with a communication device hosting a location service 11(e.g. a workstation or server that hosts a service via a networkconnection). Such a location service may include a global positioningsystem related location service or a navigational location service thatmay be hosted by a communication system. The location data of thecomputer device 1 can be determined from the location service and thelocation of certain hospitals near that location can then be determinedby the computer device 1. The computer device 1 can use such informationso that when a stroke is detected by the stroke detection device, thealert generated by the computer device for being output to the medic canalso identify a particular hospital located relatively near the computerdevice (and thus, the patient and medic) that may be best equipped totreat a stroke condition as compared to other nearby hospitals. Thealert may be output to the medic via a display located in a rear of thevehicle in which a patient may be positioned for transport. The alert orother alert related information can also be communicated to a displaydevice, speaker, or other output device that may be positioned by thesteering wheel, driver seat, or passenger seat of the vehicle (e.g.ambulance) to communicate such information to the driver or pilot of thevehicle.

It is contemplated that embodiments of the stroke detection device canalso be configured to detect other conditions of a patient. For example,embodiments of the device may be configured to detect whether a patienthas scoliosis and/or a chronic condition relating to nerve damage and/orperipheral nerve damage. As another example, the device can also beconfigured to detect whether the patient has experienced an injury to apart of his or her nervous system. The detection of such a condition canbe used to provide data to a care provider (e.g. a medic or doctor)and/or may also be used by the computer device to calibrate to thealtered physiology that exists when such a condition is detected asoccurring to help the device avoid making a false positive detection. Asyet another example, embodiments of the stroke detection device can beconfigured to determine whether a patient has undergone or is undergoingone or more types of nervous system related injuries and/or diseases.

The computer device can also be configured to account for different enduser requirements and a tolerance for false positives that may exist fora given care provider. For instance, transport to initial carefacilities may not tolerate false negatives to a higher degree than acare provider who has a CT scanner present that may be used to evaluatea patient condition for a patient that has not recently undergone atraumatic event. The computer device can be configured to account forsuch tolerance chances so that the probability of a false negative isadjusted for a given end user. Input parameters that may be provided viaan input device to the computer device can be used by the computerdevice to determine the sensitivity of the evaluation of measurementdata it may perform based on sensitivity, specificity, positivepredictive value, and negative predictive value parameters as well asother parameters a user may provide input on for use in account forvarious cost/benefit options available to a particular end user andhealth care services that end user may provide.

Embodiments of the computer device can also be configured to utilizemachine learning techniques to continually update and optimize how themeasurement data is evaluated for sub-segments of a population ofpatients that may have undergone a stroke or other neurologicalcondition. The computer device may start with a sample of a pre-selectednumber of patients (e.g. 100, 200, 300, etc.) and optimize itsmeasurement data evaluation methodology based on testing results that itsaves in its memory as more patients are evaluated by the computerdevice. The evaluation optimization process can be based on the storeddata from prior tests to provide changes to different pre-selectedvariables that are used to assess different patients having differentdemographics (e.g. black men over 80 who are under 6 feet tall, whitefemales under 60 who are between five and six feet tall, etc.). In someembodiments, multiple computer devices employed in different careenvironments may communicate the measurement data and evaluation datafrom prior testing of patients to a central server via at least onecommunication connection (e.g. a network connection, an internetconnection, etc.). The central server may evaluate that data and updatevarious variables used by the applications of those computer devices forevaluating measurement data. The updated application variables may thenbe communicated to the communication devices so that the application ofthe devices can be updated so that subsequent testing of patientsperformed by the computer devices utilized the updated evaluationmethodology and updated variable information communicated by the centralserver.

It should be understood that embodiments of the neurological conditiondetection unit can be configured to meet different sets of designcriteria. For instance, in some embodiments the computer device 1 may beincorporated into an electrocardiogram machine, which may also bereferred to as an ECG machine or an EKG machine. Such a device may beconfigured to both provide electrocardiogram sensing and recording for apatient in addition to providing stroke detection services. As anotherexample, the computer device can be configured so that the difference inslope or difference in frequency of the wave forms generated from thesensor data for the patient left and right sides is compared to eachother to determine whether a sufficiently significant difference betweenthe slopes of the wave forms at corresponding times exceeds a thresholdto detect the occurrence of a stroke. As yet another example, in someembodiments the neurological condition detection unit can be configuredto be a modular mobile device that is moveable into and out of differentvehicles while other embodiments may be designed to be incorporated intothe structure of an ambulance or other type of vehicle. As yet anotherexample, in some embodiment the electricity transmitter unit 1 g may bea separate device that is communicatively connected to the processorunit 1 a of the computer device 1 and is actuated by the computer device1 to transmit evoked potential (e.g. a shock) to the patientperiodically based on communications received from the processor 1 a ofthe computer device 1. As yet another example, the neurologicalcondition detection unit can include more than three sensors and/or morethan two evoked electrodes, multiple different types of input devicesand/or output devices and/or multiple different types of transceiverunits. In yet other embodiments, the computer device may only use oneinput/output device for providing output and allowing a user tocommunicate input and no additional or separate output or input devices.In such embodiments, such an input/output device may be an electronictablet, smart phone, touch screen display, or other type of input/outputdevice Therefore it should be understood that while certain exemplaryembodiments of the stroke detection device and methods of making andusing the same have been discussed and illustrated herein, it is to bedistinctly understood that the invention is not limited thereto but maybe otherwise variously embodied and practiced within the scope of thefollowing claims.

1-13. (canceled)
 14. A neurological condition detection unit comprising:non-transitory memory; a processor connected to the memory; a pluralityof evoked electrodes connectable to the neurological condition detectionunit such that a pre-selected number of shocks within a pre-selectedtime period is transmittable into a body of a patient via the evokedelectrodes; a plurality of sensors communicatively connectable to thememory such that measurement data relating to responses opposite sidesof the body of the patient have to the shocks is storable in the memory,the sensors being positionable on opposite sides of a body; theneurological condition detection unit configured to evaluate themeasurement data to determine that at least one of the sensors needs tobe re-positioned so that the sensors are arranged on the body in apre-selected orientation and generate output to indicate that thesensors are incorrectly positioned on the patient and requireadjustment; the neurological condition detection unit also configured toutilize the measurement data to generate at least one of wave forms andcurves that identify amplitudes for responses from the shocks theopposite sides of the body are measured to have, compare the amplitudesto determine a difference between an amplitude for a left side of thebody and an amplitude for a right side of the body that is at or exceedsa pre-selected threshold; and generate a notification to identify adetection of a neurological condition in response to a result of thecomparing of the amplitudes indicating that the difference between theamplitude for the left side of the body and the amplitude for the rightside of the body is at or exceeds the pre-selected threshold so that theneurological condition is identifiable prior to transportation of thebody to a care facility via an ambulatory vehicle; and the neurologicalcondition detection unit also configured to communicate the notificationfor output via at least one output device so that the neurologicalcondition is identifiable prior to transportation of the body to thecare facility via the ambulatory vehicle.
 15. The neurological conditiondetection unit of claim 14, wherein the neurological condition detectionunit is positioned in an ambulatory vehicle.
 16. The neurologicalcondition detection unit of claim 14, comprising: a wireless transceiverunit configured to communicatively connect the processor and the memoryto the sensors.
 17. The neurological condition detection unit of claim14, comprising: a wireless transceiver unit configured tocommunicatively connect the processor and the memory to the evokedelectrodes.
 18. The neurological condition detection unit of claim 14,comprising: a power source connected to the evoked electrodes such thatelectricity is transmittable into the body via the evoked electrodes.19. The neurological condition detection unit of claim 14, wherein: thesensors are on at least one pad that is configured to adhesively attachto the body; the evoked electrodes are on pads that are configured toadhesively attach to the opposite sides of the body.
 20. Theneurological condition detection unit of claim 14, wherein the pads eachhave a covering that removably covers adhesive of the pad that isconfigured to adhesively attach the pad to the body, the covering havingindicia identifying a location on the body to which the pad is to beattached.
 21. A neurological condition detection unit comprising: anon-transitory computer readable medium; a processor connected to thenon-transitory computer readable medium; a plurality of evokedelectrodes connectable to the neurological condition detection unit suchthat a pre-selected number of shocks within a pre-selected time periodis transmittable into a body of a patient via the evoked electrodes; aplurality of sensors communicatively connectable to the non-transitorycomputer readable medium such that measurement data relating toresponses opposite sides of the body of the patient have to the shocksis storable in the non-transitory computer readable medium, the sensorsbeing included in headgear that is wearable on the head of the patientto facilitate positioning of the sensors on the patient; theneurological condition detection unit configured to utilize themeasurement data to generate at least one of wave forms and curves thatidentify amplitudes for responses from the shocks the opposite sides ofthe body are measured to have, compare the amplitudes to determine adifference between an amplitude for a left side of the body and anamplitude for a right side of the body that is at or exceeds apre-selected threshold; and generate a notification to identify adetection of a neurological condition in response to a result of thecomparing of the amplitudes indicating that the difference between theamplitude for the left side of the body and the amplitude for the rightside of the body is at or exceeds the pre-selected threshold, whereinthe neurological condition includes a stroke; the neurological conditiondetection unit being positionable in an ambulatory vehicle; and theneurological condition detection unit configured to generate output toindicate that the evoked electrodes and/or sensors are incorrectlypositioned on the patient and require adjustment; the neurologicalcondition detection unit also configured to generate a notification foroutput via at least one output device so that the neurological conditionis identifiable prior to transportation of the body to a care facilityvia the ambulatory vehicle.
 22. The neurological condition detectionunit of claim 21, comprising: a wireless transceiver unit configured tocommunicatively connect the processor and the non-transitory computerreadable medium to the sensors.
 23. The neurological condition detectionunit of claim 21, comprising: a wireless transceiver unit configured tocommunicatively connect the processor and the non-transitory computerreadable medium to the evoked electrodes.
 24. The neurological conditiondetection unit of claim 21, comprising: a power source connected to theevoked electrodes such that electricity is transmittable into the bodyvia the evoked electrodes.
 25. The neurological condition detection unitof claim 21, wherein: the sensors are on at least one pad that isconfigured to adhesively attach to the body; the evoked electrodes areon pads that are configured to adhesively attach to the opposite sidesof the body.
 26. The neurological condition detection unit of claim 21,wherein the pads each have a covering that removably covers adhesive ofthe pad that is configured to adhesively attach the pad to the body, thecovering having indicia identifying a location on the body to which thepad is to be attached.
 27. The neurological condition detection unit ofclaim 21, wherein the evoked electrodes are connectable to a powersource of the ambulatory vehicle.
 28. The neurological conditiondetection unit of claim 21, comprising: a display communicativelyconnected to the processor.
 29. The neurological condition detectionunit of claim 28, wherein the output that is generated to indicate thatthe evoked electrodes and/or sensors are incorrectly positioned on thepatient and require adjustment is displayable on the display.
 30. Theneurological condition detection unit of claim 28, wherein theneurological detection unit is configured to generate a notification toidentify a location of at least one hospital determined to be mostcapable of providing care for the neurological condition in response todetection of the neurological condition, the notification thatidentifies the location of the at least one hospital being displayableon the display.
 31. The neurological condition detection unit of claim21, comprising: a speaker connected to the processor.
 32. Theneurological condition detection unit of claim 31, wherein the outputthat is generated to indicate that the evoked electrodes and/or sensorsare incorrectly positioned on the patient and require adjustment isaudibly output via the speaker.